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Quantification of Tenofovir Alafenamide Adherence (QUANTI-TAF)

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ClinicalTrials.gov Identifier: NCT04065347
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : November 26, 2019
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
This study is being done to evaluate the relationship between adherence to antiretroviral therapy (ART) and HIV drug concentrations in persons living with HIV (PLWH) that are taking tenofovir alafenamide (TAF). Adherence will be measured with an ingestible biosensor (digital pill). Antiretroviral drug concentrations will be measured in different types of blood cells.

Condition or disease Intervention/treatment
HIV/AIDS Adherence, Medication Device: Digital Pill

Detailed Description:
PLWH taking or initiating/re-initiating TAF will be recruited for a 16-week study. Upon entering the study, participants will be trained on the use the digital pill to objectively quantify adherence. Study participants already taking TAF will return every 4 weeks for a study visit where blood for drug concentrations will be obtained. Participants initiating/re-initiating TAF will return weekly for the first 4 weeks, at weeks 6 and 8, and every 4 weeks thereafter for a study visit where drug concentrations will be obtained.

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Study Type : Observational
Estimated Enrollment : 212 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quantification of Tenofovir Alafenamide Adherence and Exposure in Adults Living With HIV
Actual Study Start Date : November 21, 2019
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
Group 1
A total of 150 participants taking tenofovir alafenamide will be enrolled in this cohort.
Device: Digital Pill
Digital Pill over encapsulating tenofovir alafenamide ART
Other Name: etectRx ID-Cap System

Group 2
A total of 30 participants initiating/re-initiating tenofovir alafenamide will be enrolled in this cohort.
Device: Digital Pill
Digital Pill over encapsulating tenofovir alafenamide ART
Other Name: etectRx ID-Cap System




Primary Outcome Measures :
  1. Tenofovir-diphosphate (TFV-DP) in Dried Blood Spots (DBS) [ Time Frame: Week 12 ]
    Steady-state drug concentration distribution and quantiles for highly adherent (i.e. >95% of ingestions) participants.

  2. Tenofovir-diphosphate (TFV-DP) in Dried Blood Spots (DBS) [ Time Frame: Week 16 ]
    Steady-state drug concentration distribution and quantiles for highly adherent (i.e. >95% of ingestions) participants.


Biospecimen Retention:   Samples With DNA
Whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
PLWH who are initiating/re-initiating or have been on TAF for > 6 months.
Criteria

Inclusion Criteria:

  1. Females or males with HIV, able to give informed consent and comply with study procedures.
  2. Currently on (> 6 months), or planning to initiate/re-initiate TAF.

Exclusion Criteria:

  1. For females of childbearing age, active pregnancy or any intent to become pregnant
  2. Hepatitis C (HCV) infection for which treatment is anticipated within the next 16 weeks after enrollment. Treated HCV with sustained virologic response is allowable if last dose of HCV antivirals was >12 months prior to enrollment
  3. Advanced renal (eGFR <30 mL/min/1.73m**2) or liver (Child-Pugh B or C) disease
  4. History of extensive bowel surgery, gastric bypass, or gastroparesis
  5. Concomitant use of any prescription or non-prescription drug known (or with the potential) to significantly influence the PK of TAF (e.g. rifamycins, carbamazepine, phenytoin, St. John's Wort, tipranavir)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065347


Contacts
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Contact: Ryan P Coyle, BA 303-724-8612 ryan.coyle@cuanschutz.edu
Contact: Jose R Castillo-Mancilla, MD 303-724-4934 jose.castillo-mancilla@cuanschutz.edu

Locations
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United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Jose R Castillo-Mancilla, MD University of Colorado-AMC
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04065347    
Other Study ID Numbers: 19-0715
1R01AI145453-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Colorado, Denver:
Adherence
Dried Blood Spots
Tenofovir-diphosphate
Antiretroviral therapy
Tenofovir alafenamide
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases